(141 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biocompatibility of a personal lubricant, with no mention of AI or ML technology.
No.
The intended use of the device is to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication, which are not therapeutic functions.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a therapeutic or lifestyle product, not a device used to diagnose a medical condition.
No
The device description clearly states it is an "oil-based personal lubricant" and lists physical ingredients. It is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Woo More Play Coconut Love Oil's Intended Use: The intended use of this product is clearly stated as a personal lubricant for penile and/or vaginal application to enhance intimate sexual activity. It is applied directly to the body, not used to test specimens taken from the body.
- Device Description: The description confirms it's a topical lubricant with a specific formulation for that purpose.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose.
Therefore, based on the provided information, Woo More Play Coconut Love Oil is a personal lubricant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Woo More Play Coconut Love Oil is a personal lubricant for vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Woo More Play Coconut Love Oil is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Product codes
NUC
Device Description
Woo More Play Coconut Love Oil is a non-sterile, flavored, oil-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms. Its formulation consists of Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Beeswax, Deionized Water, Stevia Rebaudiana Leaf Extract, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, and Natural Flavor.
Woo More Play Coconut Love Oil is for over-the-counter (OTC) use and is packaged in 3.3 oz. non-sterile bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal, penile
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility
Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009/(R)2014) ●
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010) ●
- Vaginal Irritation (ISO 10993-23: 2021) ●
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
Shelf Life
The subject device is a non-sterile personal lubricant packaged in 3.3 oz. non-sterile bottles with a 3-month shelf-life in accordance with the results of a real-time aging study. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.
Condom Compatibility
Condom compatibility testing was not conducted for the subject device. Therefore, Woo More Play Coconut Love Oil is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
December 1, 2023
Woo Essentials, Inc. Mackie Swan CEO 1801 Brackenridge St. A Austin, TX 78704
K232093 Re: Trade/Device Name: Woo More Play Coconut Love Oil Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 1, 2023 Received: November 1, 2023
Dear Mackie Swan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232093
Device Name Woo More Play Coconut Love Oil
Indications for Use (Describe)
Woo More Play Coconut Love Oil is a personal lubricant for vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary — K232093 Woo More Play Coconut Love Oil
l. General Information on Submitter
| Applicant: | Woo Essentials, Inc. |
|---|---|
| Address: | 1801 Brackenridge St. A |
| Austin, TX | |
| 78704 | |
| Telephone: | 858-634-0994 |
| Contact Person: | Mackie Swan |
| Contact Title: | CEO |
| Woo Essentials, Inc. | |
| Email: | mackie@woomoreplay.com |
| Date Prepared: | November 29, 2023 |
II. General Information on Device
| Proprietary Name: | Woo More Play Coconut Love Oil |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
lll. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| Bloomi Delight Oil-Based Personal Lubricant | K222175 |
This predicate device has not been subject to a design-related recall.
IV. Description of Device
Woo More Play Coconut Love Oil is a non-sterile, flavored, oil-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms. Its formulation consists of Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Beeswax, Deionized Water, Stevia Rebaudiana Leaf Extract, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, and Natural Flavor.
Woo More Play Coconut Love Oil is for over-the-counter (OTC) use and is packaged in 3.3 oz. non-sterile bottles.
4
The specifications for the Woo More Play Coconut Love Oil are described in Table 1.
| Parameter | Test Method | Specification |
|---|---|---|
| Appearance | Visual | Opaque; thin liquid to semi-solid |
| Color | Visual | White to off-white |
| Odor | Olfactory | Characteristic |
| pH | USP | 4.0-5.5 |
| Viscosity | USP | 500-2,000 cPs |
| Osmolality | N/A | N/A |
| Water Activity | USP | |
| criteria for Category 2 | ||
| products. Category 2, | ||
| bacteria should show not less | ||
| than 2.0 log reduction at 14 | ||
| days and no increase from | ||
| the 14-day count to the 28- | ||
| day count. Yeast and molds | ||
| should show no increase | ||
| from the initial calculated | ||
| count at 14 and 28 days | ||
| Total Microbial Count | USP and | |
| and | ||
| Absent | ||
| Specific gravity | USP | 0.86-0.96 |
Table 1. Device Specifications
V. Indications for Use
Woo More Play Coconut Love Oil is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
VI. Substantial Equivalence Discussion
5
A comparison of the intended use and technological features of the subject and predicate devices is provided in Table 2 below:
Table 2. Intended Use and Technological Characteristics of Subject Device Compared to Predicate Device
| Characteristic /
Feature | Woo More Play Coconut
Love Oil (subject device) | Bloomi Delight Oil-
Based Personal
Lubricant (predicate
device) - K222175 | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Woo More Play Coconut Love
Oil is a personal lubricant for
penile and/or vaginal
application, intended to
lubricate, moisturize, and
enhance the ease and comfort
of intimate sexual activity and
supplement the body's natural
lubrication. This product is not
compatible with natural rubber
latex, polyurethane, and
polyisoprene condoms. | The Bloomi Delight Oil-Based
Personal Lubricant is a
personal lubricant for penile
and/or vaginal application,
intended to lubricate,
moisturize, and enhance the
ease and comfort of intimate
sexual activity and supplement
the body's natural lubrication.
This product is not compatible
with natural rubber latex,
polyurethane, and
polyisoprene condoms. | Same |
| Appearance | Opaque, thin liquid to semi-
solid | Semi-fluid | Different |
| Color | White to Off-White | Yellow | Different |
| Odor | Characteristic | Odorless | Different |
| Viscosity | 500-2,000 cPs | 2,300-20,000 cPs | Different |
| Over the Counter | Yes | Yes | Same |
| Water Activity |